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United States · US · US:68788-8254_dbbfc67e-e438-40f9-bbee-56f0d0e25a29
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116878882541100 TABLET, FILM COATED in 1 BOTTLE (68788-8254-1)
- ndc11687888254220 TABLET, FILM COATED in 1 BOTTLE (68788-8254-2)
- ndc11687888254330 TABLET, FILM COATED in 1 BOTTLE (68788-8254-3)
- ndc11687888254660 TABLET, FILM COATED in 1 BOTTLE (68788-8254-6)
- ndc11687888254990 TABLET, FILM COATED in 1 BOTTLE (68788-8254-9)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A078154
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "44YRR34555",
"rxcui": "114477",
"inchikey": "HPHUVLMMVZITSG-LURJTMIESA-N",
"display_name": "LEVETIRACETAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"52fa0eec-3dd9-59ca-e063-6394a90a9791": {
"match": "brand_token",
"title": "LEVETIRACETAM TABLET, FILM COATED [INJECTA MEDCIAL LLC]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "68788-8254_dbbfc67e-e438-40f9-bbee-56f0d0e25a29",
"productndc": "68788-8254",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078154",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jan 15, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Jan 15, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Jan 15, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078154",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20220902",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AX14.
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